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Anti-fungal
A Study Of Diflucan In Children With Ringworm Of The Scalp
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.
Eligible Conditions
- Tinea Capitis
- Ringworm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2013 Phase 3 trial • 362 Patients • NCT0073453914%
Necrotising Enterocolitis Neonatal
6%
Intestinal Perforation
5%
Neonatal Respiratory Failure
3%
Sepsis Neonatal
2%
Neonatal Respiratory Arrest
2%
Staphylococcal Sepsis
1%
Bilirubin Conjugated Increased
1%
Vena Cava Thrombosis
1%
Meconium Ileus
1%
Pneumothorax
1%
Convulsion Neonatal
1%
Intraventricular Haemorrhage Neonatal
1%
Neonatal Multi-Organ Failure
1%
Renal Failure
1%
Patent Ductus Arteriosus
1%
Colonic Stenosis
1%
Neonatal Respiratory Distress Syndrome
1%
Arthritis Bacterial
1%
Ileal Perforation
1%
Renal Failure Neonatal
1%
Intestinal Ischaemia
1%
Ileal Atresia
1%
Thrombocytopenia
1%
Soft Tissue Necrosis
1%
Gamma-Glutamyltransferase Increased
1%
Bradycardia Neonatal
1%
Endotracheal Intubation Complication
1%
Oxygen Saturation Decreased
1%
Adrenal Insufficiency
1%
Bronchopleural Fistula
1%
Pleural Effusion
1%
Pulmonary Haemorrhage
1%
Hydrocephalus
1%
Neonatal Cardiac Failure
1%
Neonatal Hypotension
1%
Deep Vein Thrombosis
1%
Osteomyelitis
1%
Group B Streptococcus Neonatal Sepsis
1%
Pneumoperitoneum
1%
Peritoneal Haemorrhage
1%
Cerebral Ventricle Dilatation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluconazole
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm AExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluconazole
FDA approved
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,716,997 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,853 Total Patients Enrolled